Events

Alerta De Seguridad para CAMERA GAMMA VERTEX TM V60; Brand Philips; Risk class III; serial numbers: 01894VM; Z01798VM; 00970VA; 40050223.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Philips Medical Systems Ltda.; ADAC Laboratories (A Philips Medical Systems Company).

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    1547
  • Fecha
    2015-03-27
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • Notas adicionales en la data
    According to the registry holder, there was an accident report of the equipment with an operator. The accident resulted in an injury to the operator.
  • Causa
    Collimation cassette misalignment on upper guide bearings when manual override causes collimator to drop and cassette.
  • Acción
    According to record holder guidelines, if the customer visually identifies a misalignment at the top and / or bottom of the guide rail between the cabinet and the car, the collimator replacement procedure should not be continued. The misalignment problem can only be solved during a maintenance operation.

Device

CAMERA GAMMA VERTEX TM V60; Brand Philips; Risk class III; serial numbers: 01894VM; Z01798VM; 009...

Manufacturer

Philips Medical Systems Ltda.; ADAC Laboratories (A Philips Medical Systems Company)
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    ANVSANVISA